Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted on a Government Accountability Office report recommending that certain high-risk medical devices receive more stringent reviews by the Food and Drug Administration or be reclassified.
In the article, titled, “GAO: More Stringent FDA Review Needed For Certain Devices Before Reaching Market,” Thompson said the GAO findings were generally positive, because they are a “tacit, overall validation” of how the review process works for most devices. For certain high-risk devices, Thompson said, the FDA has lacked resources to address the issues adequately.
Thompson also said there is no suggestion that the devices that reached the market through the review standards set for lower-risk devices are unsafe. Thompson expects that, for the 20 categories of devices that still could be cleared through this lower-risk process, regulators eventually will put the devices into class II, meaning pre-market approvals won’t be needed.